FDA approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these treatments. “Today’s approval is a first-of-its-kind therapy that can potentially save lives following overdose or life-threatening toxicity from these chemotherapy...
Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
